Resource Library

Regulatory Briefs

An overview of 21 CFR Part 812: Investigational Device Exemptions (IDEs)

Regulatory Brief

An overview of 21 CFR Part 812: Investigational Device Exemptions (IDEs)

An overview of 21 CFR Part 820 - quality systems for medical device manufacturers

Regulatory Brief

An overview of 21 CFR Part 820 - quality systems for medical device manufacturers

An overview of 21 CFR Part 11 regulations for medical device companies

Regulatory Brief

An overview of 21 CFR Part 11 regulations for medical device companies